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ADEC 249th meeting resolutions, 8 December 2006

Australian Drug Evaluation Committee

8 December 2006

Published in the Commonwealth of Australia Gazette, No. GN 1, 10 January 2007

GAZETTAL NOTICE

THERAPEUTIC GOODS ACT 1989

AUSTRALIAN DRUG EVALUATION COMMITTEE

RECOMMENDATIONS

The 249th (2006/6) meeting of the Australian Drug Evaluation Committee (ADEC) (8 December 2006) resolved to advise the Parliamentary Secretary to the Minister for Health and Ageing and the Secretary, Department of Health and Ageing that the following medicines should be approved for registration, subject to the resolution of all outstanding matters to the satisfaction of the Committee and the Therapeutic Goods Administration. These recommendations for approval may be subject to specific conditions.

RESOLUTION NO 9012

There should be no objection to approval of the submission from Pfizer Australia Pty Ltd to register CHAMPIX tablets containing the new chemical entity varenicline (as tartrate) 0.5 mg and 1.0 mg for the indication:

As an aid for smoking cessation in adults over the age of 18 years.

RESOLUTION NO 9014

There should be no objection to approval of the submission from Novo Nordisk Pharmaceuticals P/L to register NOVORAPID and NOVORAPID INNOLET injections containing the re-expressed insulin aspart (rys) 100 IU/mL produced by the NN2000 manufacturing process; NOVORAPID PENFILL, NOVORAPID FLEXPEN, NOVOMIX 30 PENFILL and NOVOMIX 30 FLEXPEN injections containing the NN2000 process insulin aspart (rys) 300 IU/3 mL for the indication:

Treatment of diabetes mellitus.

RESOLUTION NO 9016

There should be no objection to approval of the submission from Schering-Plough Pty Limited to register REMICADE powder for injection containing infliximab 100 mg for the new indication:

Treatment of moderately severe to severe active ulcerative colitis in patients who have had an inadequate response to conventional therapies.

RESOLUTION NO 9017

There should be no objection to approval of the submission from Novartis Pharmaceuticals Australia Pty Limited to register FORADILE CERTIHALER powder for inhalation containing eformoterol fumarate dihydrate 10 µg per actuation for the indication:

Long term regular treatment of reversible airways obstruction in asthma (including nocturnal asthma and exercise induced asthma) in patients 13 years or more who are receiving inhaled or oral corticosteroids. It should not be used in patients whose asthma can be managed by occasional use of short-acting inhaled β2 agonists.

RESOLUTION NO 9019

There should be no objection to approval of the submission from Alphapharm Pty Ltd to extend the indication of ERBITUX injection containing cetuximab 2 mg/mL to include:

Treatment of patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN), in combination with radiotherapy.

RESOLUTION NO 9020

There should be no objection to approval of the submission from Bristol-Myers Squibb Australia Pty Ltd to register SPRYCEL tablets containing the new chemical entity dasatinib 20 mg, 50 mg and 70 mg for the indications:

Treatment of adults aged 18 years and over with:

  • All phases of chronic myeloid leukaemia (CML), with resistance or intolerance to prior therapy including imatinib;
  • Philadelphia chromosome positive (Ph+ve) acute lymphoblastic leukaemia (ALL) with resistance or intolerance to prior therapy.

RESOLUTION NO 9022

There should be no objection to approval of the submission from Ballia Holdings P/L to register THELIN tablet containing the new chemical entity sitaxentan sodium 100 mg for the indication:

Treatment of pulmonary arterial hypertension (PAH) in patients with WHO Functional Class III symptoms to improve exercise capacity. Efficacy has been shown in primary pulmonary hypertension and in pulmonary hypertension associated with connective tissue disease and congenital heart disease.

RESOLUTION NO 9023

There should be no objection to approval of the submission from Bristol-Myers Squibb Australia Pty Ltd to register DEFINITY suspension for injection containing the new chemical entity perflutren 1.1 mg/mL inside lipid microspheres for the indications:

For use in patients:

  • for contrast-enhanced diagnostic ultrasound imaging to improve characterisation of focal lesions of the liver and kidney
  • with suboptimal echocardiograms to provide opacification of cardiac chambers, improvement of left ventricular endocardial border delineation and assessment of regional wall motion at both rest and stress

RESOLUTION NO 9024

There should be no objection to approval of the submission from Novartis Pharmaceuticals Australia Pty Limited to register SEBIVO film coated tablet containing the new chemical entity telbivudine 600 mg for the indication:

Treatment of HBeAg-positive or HBeAg-negative chronic hepatitis B patients who have compensated liver disease, evidence of ongoing viral replication and active liver inflammation and who are nucleoside analogue-naïve.

RESOLUTION NO 9025

There should be no objection to approval of the submission from Abbott Australasia Pty Ltd to register ZEMPLAR capsules containing the new chemical entity paricalcitol 1 µg, 2 µg and 4 µg and ZEMPLAR injections containing paricalcitol 5 µg/1 mL and 10 µg/2 mL for the indication:

Treatment of the biochemical manifestations of secondary hyperparathyroidism associated with chronic kidney disease.